Debunking the Myth: ‘Gene Patents’ are not necessary for healthcare innovation.

Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built. These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear alone the cost of development of these inventions into useful products.

It is precisely these types of early-stage companies that hold roughly 2/3 of the future clinical pipeline for patients, and are developing novel DNA-based approaches to dealing with environmental contamination, climate change, renewable energy, and more sustainable agriculture. Without these basic patents, these early-stage companies will not be able to attract the necessary funding for further R&D and to ultimately develop an approvable product based off of the original DNA-based invention.

Only 30% of biological therapeutics that make it as far as human trials succeed in gaining regulatory approval. (See, e.g., id. at 481.)

Most biotechnology firms are emerging firms with 50 or fewer employees working on their first products, a process that can take 15 years or more. (Guide to Biotechnology).

The stage in a company’s lifecycle after the point of basic discovery but before proof of concept has often been described as the “valley of death,” during which tens or hundreds of millions of dollars are needed to take the invention to the next stage of development.